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Clinical Trial of Cinobufacini Injection Combined With Oxaliplatin Regimen on Gastrointestine Carcinoma

Primary Purpose

Gastrointestinal Neoplasms

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Cinobufacini injection
chemotherapy
Sponsored by
Xiaonan Cui
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age:18-70
  • male and female
  • signed the informed consent form.
  • Diagnosis:Gastrointestinal cancer diagnosed by imaging,cell and pathology report.
  • Eastern Cooperative oncology Group(ECOG)O-2,life expectancy more than 3 months.
  • Indication for Chemotherapy,no contraindication.
  • First time chemotherapy or at least 6 months after last chemotherapy and radiotherapy.
  • At least 8 weeks after last biotherapy.
  • Surgery:had not received transplantation surgery,at least 2 weeks after last major surgery.

Exclusion Criteria:

  • Chemotherapy is contraindicated.
  • Have the primary disease can cause the neuropathy.
  • A history of other malignant tumor in recent 5 years.
  • Less than 6 months after last chemotherapy or radiotherapy.
  • Less than 8 weeks after last biotherapy.
  • Cinobufotalin allergy.
  • Had received transplantation surgery,less than 2 weeks after last major surgery.
  • Other researchers think is not suitable for this clinical trail.

Sites / Locations

  • The First Affiliated Hospital of Dalian Medical University
  • Liaoning Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Cinobufacini injection

Control group

Arm Description

Capsule Dosage and frequency:This group receives cinobufacini injection 20ml mixed with 5% Glucose injection 500ml started at the first day of chemotherapy until seven days once a day. Duration:6 chemotherapy cycles.

Only receive the same chemotherapy with the experimental groups.No Cinobufacini injection.And have the same adjuvant treatment with the experimental groups.

Outcomes

Primary Outcome Measures

neural electrophysiological test

Secondary Outcome Measures

The quality of life questionnaire(QLQ)-C30
National Cancer Institute(NCI)Common Toxicity Criteria
Levi sensory nerve toxicity classification standard
image test
inflammatory cytokines,in blood.
For example:Interleukin(IL)-6,tumor necrosis factor(TNF)etc,in bood
peroxidase reaction,in blood.
immune cell number ratio,in blood.
stress hormone,in blood.
Estradiol(Female),testosterone(male)etc,in bood.

Full Information

First Posted
August 1, 2016
Last Updated
August 8, 2016
Sponsor
Xiaonan Cui
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1. Study Identification

Unique Protocol Identification Number
NCT02860429
Brief Title
Clinical Trial of Cinobufacini Injection Combined With Oxaliplatin Regimen on Gastrointestine Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaonan Cui

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The clinical trail of Cinobufacini injection combined with Oxaliplatin regimen on gastrointestine carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group receives Cinobufotalin 20ml mixed with 5% Glucose injection 500ml from the first day of chemotherapy until seven days in addition to the chemotherapy.The control group only receive the same chemotherapy with the treatment group.Both group have the same adjuvant therapy.Mainly to study of oxaliplatin into Cinobufacini injection leads to the influence of the peripheral nerve toxicity.Clinical evaluation includes neural electrophysiological test,chemotherapy drug toxicities,quality of life(QOL),etc.Blood biochemistry tests mainly include inflammatory cytokines,peroxidase reaction,immune cell number ratio and stress hormone,etc.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cinobufacini injection
Arm Type
Experimental
Arm Description
Capsule Dosage and frequency:This group receives cinobufacini injection 20ml mixed with 5% Glucose injection 500ml started at the first day of chemotherapy until seven days once a day. Duration:6 chemotherapy cycles.
Arm Title
Control group
Arm Type
Other
Arm Description
Only receive the same chemotherapy with the experimental groups.No Cinobufacini injection.And have the same adjuvant treatment with the experimental groups.
Intervention Type
Drug
Intervention Name(s)
Cinobufacini injection
Intervention Description
cinobufacini injection 20ml mixed with 5% Glucose injection 500ml started at the first day of chemotherapy until seven days once a day.
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Description
Chemotherapy is the oxaliplatin combination with fluorouracil regimen.
Primary Outcome Measure Information:
Title
neural electrophysiological test
Time Frame
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),up to 6 months
Secondary Outcome Measure Information:
Title
The quality of life questionnaire(QLQ)-C30
Time Frame
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
Title
National Cancer Institute(NCI)Common Toxicity Criteria
Time Frame
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
Title
Levi sensory nerve toxicity classification standard
Time Frame
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
Title
image test
Time Frame
For adjuvant chemotherapy patients every 3 months.For saving chemotherapy patients every 2 months.anticipate up to 1 years.
Title
inflammatory cytokines,in blood.
Description
For example:Interleukin(IL)-6,tumor necrosis factor(TNF)etc,in bood
Time Frame
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
Title
peroxidase reaction,in blood.
Time Frame
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
Title
immune cell number ratio,in blood.
Time Frame
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
Title
stress hormone,in blood.
Description
Estradiol(Female),testosterone(male)etc,in bood.
Time Frame
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age:18-70 male and female signed the informed consent form. Diagnosis:Gastrointestinal cancer diagnosed by imaging,cell and pathology report. Eastern Cooperative oncology Group(ECOG)O-2,life expectancy more than 3 months. Indication for Chemotherapy,no contraindication. First time chemotherapy or at least 6 months after last chemotherapy and radiotherapy. At least 8 weeks after last biotherapy. Surgery:had not received transplantation surgery,at least 2 weeks after last major surgery. Exclusion Criteria: Chemotherapy is contraindicated. Have the primary disease can cause the neuropathy. A history of other malignant tumor in recent 5 years. Less than 6 months after last chemotherapy or radiotherapy. Less than 8 weeks after last biotherapy. Cinobufotalin allergy. Had received transplantation surgery,less than 2 weeks after last major surgery. Other researchers think is not suitable for this clinical trail.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaonan Cui, MD,PhD
Phone
+8618098876725
Email
cxn23@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Zhang
Phone
+8613898872185
Email
zzzrrr1234@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaonan Cui, MD,PhD
Organizational Affiliation
The First Affiliated Hospital of Dalian Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rui Zhang
Organizational Affiliation
Liaoning cancer province
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaonan Cui
Phone
+8618098876725
Email
cxn23@sina.com
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui Zhang
Phone
+8613898872185
Email
zzzrrr1234@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Clinical Trial of Cinobufacini Injection Combined With Oxaliplatin Regimen on Gastrointestine Carcinoma

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